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Last Updated: July 11, 2020

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Lithium carbonate - Generic Drug Details

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What are the generic drug sources for lithium carbonate and what is the scope of freedom to operate?

Lithium carbonate is the generic ingredient in seven branded drugs marketed by Noven Therap, Able, Alembic Ltd, Apotex Inc, Glenmark Generics, Hetero Labs Ltd Iii, Hikma, Mylan, Usl Pharma, Watson Labs, Solvay, Jds Pharms, Alembic Pharms Ltd, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Mylan Pharms Inc, Unique Pharm Labs, Ani Pharms Inc, Bayer Pharms, Pfizer, and Sun Pharm Inds Inc, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for lithium carbonate. Twenty-three suppliers are listed for this compound.

Drug Prices for lithium carbonate

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Drug Sales Revenue Trends for lithium carbonate

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Recent Clinical Trials for lithium carbonate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
All India Institute of Medical Sciences, BhubaneswarPhase 4
StemCyte, Inc.Phase 2
Amarex Clinical ResearchPhase 2

See all lithium carbonate clinical trials

Pharmacology for lithium carbonate
Drug ClassMood Stabilizer
Medical Subject Heading (MeSH) Categories for lithium carbonate

US Patents and Regulatory Information for lithium carbonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Intl Pharms LITHIUM CARBONATE lithium carbonate TABLET, EXTENDED RELEASE;ORAL 076490-001 Jun 17, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan LITHIUM CARBONATE lithium carbonate CAPSULE;ORAL 076243-001 Jun 27, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma LITHIUM CARBONATE lithium carbonate CAPSULE;ORAL 017812-002 Jan 28, 1987 AB RX Yes No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii LITHIUM CARBONATE lithium carbonate CAPSULE;ORAL 090702-001 Sep 25, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Jds Pharms ESKALITH CR lithium carbonate TABLET, EXTENDED RELEASE;ORAL 018152-001 Mar 29, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma LITHIUM CARBONATE lithium carbonate TABLET, EXTENDED RELEASE;ORAL 076170-001 Jun 10, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc LITHIUM CARBONATE lithium carbonate TABLET, EXTENDED RELEASE;ORAL 202219-001 Aug 8, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Harvard Business School
Mallinckrodt
Boehringer Ingelheim
Medtronic

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